Trial Condition(s):

Venous thrombosis

Deep vein thrombosis treatment with the Oral Direct Factor Xa Inhibitor Rivaroxaban in patients using a strong CYP 3A4 inducer

Bayer Identifier:

13238

ClinicalTrials.gov Identifier:

NCT00786422

EudraCT Number:

2008-003303-31

EU CT Number:

Not Available

Study Completed

Trial Purpose

This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire 3-month study duration.

Inclusion Criteria
- Confirmed acute symptomatic proximal deep- vein thrombosis and/or pulmonary embolism
  - Concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin, rifampicin/rifampin, and rifabutin)
Exclusion Criteria
- Legal lower age limitations (country specific)
 - Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of deep -vein thrombosis and/or pulmonary embolism 
 - Other indication for vitamin K antagonist (VKA) than deep -vein thrombosis and/or pulmonary embolism
  - Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole) 
 - Use of the strong CYP 3A4 inducers phenobarbital/primidone or St John's Wort

Trial Summary

Enrollment Goal
25
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

Praxis Hr. Dr. P. Baron von Bilderling

München, Germany, 80331

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Academisch Medisch Centrum Universiteit van Amsterdam

AMSTERDAM, Netherlands, 1105 AZ

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Mayo Clinic

Roodepoort, South Africa, 1724

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Unitas Hospital

Pretoria, South Africa, 0157

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Barzilai Medical Center

Ashkelon, Israel, 7830604

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Redcliffe District Hospital

Redcliffe, Australia, 4020

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Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

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University of Debrecen

Debrecen, Hungary, 4032

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Real Benemérita Ass Portug Beneficiência-Hosp S. Joaquim

São Paulo, Brazil, 01323-001

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IRCCS Policlinico San Matteo

Pavia, Italy, 27100

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Pretoria Academic Hospital New

Pretoria, South Africa, 0084

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Helderberg Medical Clinical Trials

Somerset West, South Africa, 7130

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University of Witwatersrand

Johannesburg, South Africa, 2132

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Clinical Projects Research SA

Worcester, South Africa, 6850

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Folateng Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, South Africa, 2193

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Edith Wolfson Medical Center

Holon, Israel, 58100

Trial Design